HIV and the Blood Supply

An Analysis of Crisis Decisionmaking

Author: Stoto, Michael A.; Sox, Harold C., Jr.; Leveton, Lauren B.
Publisher: National Academies Press
ISBN: 9780309103756
eISBN Pdf: 9780309588270
eISBN Epub: 9780309176132
Place of publication: United States
Year of digital publication: 1995
Month: October
Pages: 349
DDC: 616
Language: English

Caption

During the early years of the AIDS epidemic, thousands of Americans became infected with HIV through the nation's blood supply. Because little reliable information existed at the time AIDS first began showing up in hemophiliacs and in others who had received transfusions, experts disagreed about whether blood and blood products could transmit the disease.

During this period of great uncertainty, decision-making regarding the blood supply became increasingly difficult and fraught with risk. This volume provides a balanced inquiry into the blood safety controversy, which involves private sexual practices, personal tragedy for the victims of HIV/AIDS, and public confidence in America's blood services system.

The book focuses on critical decisions as information about the danger to the blood supply emerged. The committee draws conclusions about what was done—and recommends what should be done to produce better outcomes in the face of future threats to blood safety.

The committee frames its analysis around four critical area:

Product treatment—Could effective methods for inactivating HIV in blood have been introduced sooner?
Donor screening and referral—including a review of screening to exlude high-risk individuals.
Regulations and recall of contaminated blood—analyzing decisions by federal agencies and the private sector.
Risk communication—examining whether infections could have been averted by better communication of the risks.

HIV AND THE BLOOD SUPPLY
Copyright
Preface
- REFERENCE
Contents
Executive Summary
- HISTORY
  - The Risk of AIDS
  - Immediate Responses to Evidence of Blood-Borne AIDS Transmission
  - Opportunities to Reformulate Policy
  - Research Activities
- FINDINGS
  - Product Treatment
  - Donor Screening and Deferral Policies
  - Regulations and Recall
  - Communication to Physicians and Patients
- CONCLUSIONS
  - Decisionmaking Under Uncertainty
  - Bureaucratic Management of Potential Crises
- RECOMMENDATIONS
  - The Public Health Service
  - The Centers for Disease Control and Prevention
  - The Food and Drug Administration
  - Communication to Physicians and Patients
- REFERENCES
1 Introduction
- HIV INFECTION VIA BLOOD TRANSFUSION
- THE COMMITTEE'S CHARGE
- ORGANIZATION OF THE REPORT
- REFERENCES
2 The U.S. Blood Supply System
- INTRODUCTION
- BLOOD AND BLOOD PRODUCTS
  - Whole Blood and Components
  - Plasma and Derivatives
    - Plasma Collection
    - Plasma Processing
  - Blood and Blood Components Distribution
- BLOOD COLLECTION ORGANIZATIONS
  - Community Blood Banks
  - The American Red Cross Service
  - Hospital Blood Banks
- PROFESSIONAL ASSOCIATIONS
  - American Association of Blood Banks
    - AABB Inspection and Accreditation Program
  - Council of Community Blood Centers
  - American Blood Resources Association
- HEMOPHILIA ORGANIZATIONS
  - The Nature of Hemophilia
  - Hemophilia Treatment Centers
  - National Hemophilia Foundation
    - Medical and Scientific Advisory Council
- ROLE OF THE U.S. PUBLIC HEALTH SERVICE
  - National Blood Policy of 1973
  - Public Health Service
  - Centers for Disease Control and Prevention
  - National Institutes of Health
    - National Institute of Allergy and Infectious Diseases
    - National Heart, Lung, and Blood Institute
  - Food and Drug Administration
    - Blood Products Advisory Committee
- BLOOD AND BLOOD PRODUCT REGULATION
  - Statutory Background
    - Biologics Act
    - Public Health Service Act
    - Blood Shield Laws
  - Federal Licensure of Blood Collection Organizations
    - Establishment Licensure and Registration
    - Product Licensure
    - Other Required Licensure
- REGULATORY AUTHORITY OF THE FDA
  - Compliance with Regulations
  - Recall Policy
- SUMMARY
- REFERENCES
3 History of the Controversy
- INTRODUCTION
- THE RISK OF AIDS
  - Kaposi's Sarcoma and PCP in Homosexual Men
  - Opportunistic Infections Among Heterosexual Intravenous (IV) Drug Users and Haitian Immigrants
  - Increased Risk Among Individuals with Hemophilia and a Similarity to Hepatitis B
  - Further Evidence of Sexual and Blood-Borne Transmission of AIDS
  - Summary
- IMMEDIATE RESPONSES TO EVIDENCE OF BLOOD-BORNE AIDS TRANSMISSION
  - The CDC's Public Meeting
  - The Blood Bank Community's Statement
  - Position of the National Hemophilia Foundation
  - Position of the Plasma Fractionation Industry
  - Federal Recommendations on the Prevention of AIDS
  - Summary and Comment
- RECONSIDERING THE EVIDENCE: FURTHER ATTEMPTS TO FORMULATE POLICIES
  - Summary and Comment
- RESEARCH ACTIVITIES
  - The Public Health Service Effort
  - Isolation of the Virus and Development of a Screening Test
  - Summary and Comment
- REFERENCES
4 Product Treatment
- INTRODUCTION
- CRITICAL TIME PERIOD: 1970-1983
  - Hepatitis
  - Viral Inactivation of AHF Concentrate
    - Early Methods
    - Studies by U.S. Plasma Fractionation Companies
  - Problems of Viral Inactivation Development
  - Impact of the First Reported Cases of AIDS in Individuals with Hemophilia
  - Federal Research Support for Viral Inactivation
  - Specific Viral Inactivation Methods
    - Testing for the Effectiveness of the Inactivation Process
    - FDA Approval and Licensing of Treated Factor VIII
- ANALYSIS AND CONCLUSIONS
- SUMMARY
- AFTERWARD
  - Subsequent Events
  - Current Procedures and Challenges
- REFERENCES
5 Donor Screening and Deferral
- INTRODUCTION
  - Critical Events
    - Critical Event 1
    - Critical Event 2
  - Explanatory Hypotheses
- DONOR SCREENING PRACTICES
  - Hepatitis
  - Donor Pools
  - Early Donor Screening Practices
- ANALYSIS AND FINDINGS
  - January 4, 1983, CDC Meeting
    - Outcomes of the Meeting
    - Donor Questioning and Opposition to It
    - Surrogate Testing and Opposition to It
    - Criticism of the CDC's Data and Motives
    - Risk Assessment
    - Lack of Leadership
    - Conclusions
  - December 1983 Blood Products Advisory Committee Meeting
    - Interim Local Efforts to Screen Aggressively
    - Reliability of Surrogate Tests
    - Task Force Report on Surrogate Testing
    - Comment on the Blood Products Advisory Committee
    - Informing the Public
    - AIDS Politics
- CONCLUSIONS
  - Hypothesis One
  - Hypothesis Two
    - Political Factors
    - Ideological Factors
    - Organizational Factors
    - Historical Factors
- AFTERWORD
  - Donor Screening 1985–1995
    - HIV
    - Hepatitis
    - HTLV-I and HTLV-II
  - Current Donor Screening Procedures
  - Current Infectious Risk Through Blood Transfusion
- REFERENCES
6 Regulations and Recall
- INTRODUCTION
- FRAMEWORK OF ANALYSIS
  - Critical Events
    - Critical Event 1
    - Critical Event 2
    - Critical Event 3
    - Critical Event 4
  - FDA Regulatory Authority and Practice
  - Explanatory Hypotheses
- FINDINGS AND CONCLUSIONS
  - FDA Letters of March 1983
    - Analysis
    - Summary and Conclusions
  - Nonautomatic Recalls
    - Analysis
    - Summary and Conclusions
  - Heat-Treated AHF Concentrate and the FDA's Recall Policy
    - Analysis
    - Summary and Conclusions
  - Lookback and Notification of Individuals Transfused with Contaminated Blood Products
    - Analysis
    - Summary and Conclusions
- INFLUENCE AND RESPONSIBILITIES OF OTHER ORGANIZATIONS
  - Governmental Organizations
  - Nongovernmental Organizations
  - Implications
- THE ADVANTAGES OF MARGINAL THINKING
  - Lookback and Notification
  - Removal of Untreated AHF Concentrate
  - Use of Screened Whole Blood
  - Destruction of Potentially Contaminated Cryoprecipitate
  - Innovative Techniques for Pooling Plasma
  - Testing Previously Untested Blood and Plasma for HIV
- SUMMARY
- REFERENCES
7 Risk Communication to Physicians and Patients
- INTRODUCTION
- FRAMEWORK FOR ANALYSIS
  - Critical Questions
  - Critical Factors
  - The Role of the National Hemophilia Foundation
- RISK REDUCTION OPTIONS
  - Specific Options
  - The Process for Developing NHF Guidelines
- CASE STUDIES
  - Case Study One: Conviction and Change
  - Case Study Two: Reduction in Use of AHF Concentrate
  - Case Study Three: Continue AHF Concentrate Treatment
  - Case Study Four: Prescribing Cryoprecipitate for a Newborn and Continuing AHF Concentrate Treatment For a Four-Year-Old
  - Case Study Five: A Transfusion Case
  - Summary of the Case Studies
- OBSTACLES TO COMMUNICATION
  - Institutional Obstacles
    - Resources and Expertise of the NHF
    - The NHF and the Plasma Fractionation Industry
    - Communication Style of the NHF
  - Social and Cultural Obstacles
- CONCLUSIONS
- REFERENCES
8 Conclusions and Recommendations
- GENERAL CONCLUSIONS
  - Decisionmaking Under Uncertainty
    - Risk Perception
    - Risk Assessment Versus Risk Management
    - Consider the Full Range of Possibilities
    - Risk Reduction Versus Zero Risk
    - Risk Communication
  - Bureaucratic Management of Potential Crises
    - Coordination and Leadership
    - Advisory Mechanisms
    - Analytic Capability and Long-Range Vision
  - Presumptive Regulatory and Public Health Triggers
    - Product Treatment
    - Donor Screening
    - Recall
    - Communication to Patients and Providers
- RECOMMENDATIONS
  - The Public Health Service
    - Leadership
    - Blood Safety Council
    - Compensation Policy
  - The Centers for Disease Control and Prevention
    - Early Warning Systems
    - Surveillance
  - The Food and Drug Administration
    - Risk Reduction
    - Decision Processes
    - Regulatory Efforts
    - Advisory Committees
  - Communication to Physicians and Patients
    - Clinical Practice
    - Credibility
- REFERENCES
Appendixes
- A Individuals Interviewed by the Committee
- B Individuals Providing Oral and Written Testimony (for a public meeting held September 12, 1994)
- C Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Asse...
- D Key Documents Provided to the Committee
- E Glossary of Acronyms and Terms
  - Acronyms
  - Terms
  - SOURCES
- F Committee and Staff Biographies
  - COMMITTEE
  - STAFF BIOGRAPHIES
Index